Surgical instruments are often transported in trays prior to use. The instruments are usually laid out in a certain way in the tray and subjected to sterilization in a steam autoclave or similar sterilization apparatus. In order to maintain separations between the various instruments in the tray, the instruments are supported or retained by brackets, clips, posts or other fixation devices positioned in the tray. Following sterilization, the tray full of instruments is transported to an operating room and placed close to the surgical team whose members withdraw the instruments from the tray as needed for a particular surgical procedure. Many times, the instruments are selectively arranged in the tray so that they can be picked from the tray in the general order that they are needed for the particular procedure. Examples of such trays are found in U.S. Pat. Nos. 4,643,303; 5,424,048 and 5,492,671.
As seen from the above patents, the known devices for organizing and fixating medical instruments in a tray include various types of brackets, clips and posts which project up from the bottom of the tray, the instruments being held in place within slots and clip openings and/or between the posts. A plurality of such fixation devices are spaced running parallel or perpendicular to each other in the tray so that they engage and support the opposite sides or ends of various different length instruments.
Most prior art fixation devices are able to effectively locate and hold instruments which are more or less straight and regularly shaped. However, they are not particularly suitable for fixating oddly or irregularly shaped instruments such as retractors and other longer instruments that have, e.g. ring handles. This is because there is insufficient flexibility in the placement of the various fixation devices within the tray as to enable the devices to closely engage the instruments while still organizing the instruments in an efficient layout within the tray. This results from the fact that the fixation devices often are plugged into the ventilation holes usually present in the bottom of the tray such that a fixation device only can be placed where there are holes in the bottom of the tray.
As the number of such holes is limited by manufacturing cost, required tray bottom strength and the need to prevent the instruments from projecting through the holes, so also are the positions of the various fixation devices. Consequently, either the tray contains too few properly fixated instruments or a larger number of instruments some of which may not be properly fixated. Thus, if the tray is shaken or tilted, instruments may become disengaged from the fixation devices and assume skewed positions in the tray so that they may become damaged and difficult to remove without upsetting other instruments in the tray. In extreme cases, loose instruments may even fall out of the tray and become contaminated. Since a tray may contain a complete set of instruments needed for a particular surgical procedure, this may require that another full tray of sterilized instruments be made available to the surgical team.
Another consideration is that the instruments required to perform a specific surgical procedure may vary greatly between hospitals and even surgical teams within specific hospitals. Therefore, it is practically impossible to design a standard tray configuration that will be acceptable for all hospitals and surgical teams. Thus, an optimum instrument fixation arrangement is one which is enormously flexible so that it can be customized to each individual hospital and surgical team, because the numbers and types of instruments being presented in the trays change constantly.
In order to overcome the aforesaid problems of the prior art, there is proposed in U.S. Pat. No. 5,827,487 a surgical instrument fixation device for use in a sterilization tray, comprising a rail of optional length and having at least two pegs projecting from the underside of the rail which are sized and spaced apart so as to be able to plug into at least two of the ventilation holes in the bottom wall of the tray. As disclosed in the aforesaid U.S. Pat. No. 5,827,487, the ventilation holes are usually arranged in a rectangular array of columns and rows so that a rail can be positioned at any location within a column or row, i.e. running parallel or perpendicular. Typically, the rails are releasably fixed in position by threaded fasteners driven from the underside of the tray.
However, since surgical instruments come in a wide variety of shapes and forms, it is impractical to have a single rail type fixation device for all types of surgical instruments. Thus, the art has developed various systems wherein supports and dividers for the surgical instruments are provided in modular or kit form for selective positioning within the tray, for example, by plugging selected support elements through holes in a portion of the tray and fixing the element in place. The support elements can thus be arranged to match the shape of the surgical instrument to be sterilized.
Examples of such products are shown in U.S. Pat. No. 4,135,868 to Sheinholz and U.S. Pat. No. 5,384,103 to Miler. Similar products are commercially available from companies such as Poly-Vac, Incorporated of Manchester, N.H. and other suppliers. Some of these prior devices include integrally molded stubs, for example positioned on the bottom of the flexible inserts, which stubs can be locked into the ventilation holes in the tray as shown, for example, in FIG. 1 of Miller U.S. Pat. No. 5,384,103. They may also comprise separate, rigid holding elements such as shown in FIG. 3 of the above '103 patent where a rigid holder for the support element is fastened by threaded fasteners to the tray or to a shelf carried by the tray. In the '868 patent, the support element for a soft sponge rubber, constituting a hold down pad, is supported by a channel member having outwardly extending buttons which can be forced into ventilation holes in the cover or base of the sterilizing tray. Another prior U.S. patent, U.S. Pat. No. 4,798,292 shows hollow pegs having elongated legs which are used for attachment to a perforated sterilizer tray.
While all of the systems described in the prior patents and commercially available products provide a certain amount of flexibility, they do not provide both strong security for the support members and low cost. Nor do they allow for ease of removal of a securely mounted support so that the supports can be differently positioned in the sterilization trays for holding different shapes of surgical instruments to be sterilized.
In order to address this latter problem, there is described in U.S. Pat. No. 5,599,512 a commercially available (from Poly Vac, Inc., of Manchester, N.H.) sterilization support element provided with sets of resiliently deformable bayonet type fingers for locking the support elements in position in ventilation holes in bottom wall of a sterilization tray. The support elements are simply and easily removed and repositioned in the tray by means of a simple tool which engages the ends of the bayonet fingers, and pushes them back through the holes.
While all of the systems described in the above prior patents, and in commercially available products provide a certain amount of flexibility, they all have disadvantages. They all require tools for assemblying and/or removing the supports or dividers. Also, those prior art systems employing threaded fasteners, locking rings or the like, require extra parts counts. Additionally, since the mounting holes are arranged in parallel rows, standard fixation devices and separators are limited to parallel and/or perpendicular positioning relative to one another.